Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
J
Jonathan L. Berkowitz, MD, PhD
Primary Investigator
Administratively Closed
18 years - 130 years
All
Phase
2
531 participants needed
1 Location
Brief description of study
TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of
Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in
Patients with Advanced/Metastatic Solid Tumours.
Detailed description of study
This Phase II, open-label, uncontrolled, multicentre study evaluating the efficacy and safetyDato-DXd as monotherapy (MONO) and in combination with anticancer agents (COMBO) in
various advanced solid tumour types.
This study has a modular design, as such a master protocol with independent substudiesbles simultaneous evaluation of the safety profile, recommended Phase II dose (RP2D), andy of Dato-DXd in multiple disease populations and treatment combinations. This study
will evaluate various solid tumour types, including endometrial cancer (Substudy 1), gastric(Substudy 2), metastatic castration-resistant prostate cancer (mCRPC) (Substudy 3),varian cancer (Substudy 4), and colorectal cancer (CRC) (Substudy 5) in the advanced org. Within each substudy, Dato-DXd will be evaluated as monotherapy (for allubstudies except Substudy 2, (Gastric Cancer) and in combination with approved or novelgents that may be active in the tumour type being evaluated.(AZD5305,
Durvalumab).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Endometrial Cancer, Gastric Cancer, Metastatic Castration-resistant Prostate Cancer, Ovarian Cancer, Colorectal Cancer
-
Age: 18 years - 130 years
-
Gender: All
Key Inclusion Criteria:
- Male and female, ≥ 18 years
- Histologically or cytologically documented advanced or metastatic malignancy.
- At least 1 lesion not previously irradiated that qualifies as a RECIST 1.1 targetbaseline Substudy 3 (mCRPC) allows enrolment of participants with nonurable (by RECIST 1.1) bone metastatic disease.
- Adequate bone marrow reserve and organ function within 7 days beforedomization/treatment
- Minimum life expectancy of 12 weeks.
Key Exclusion Criteria:
- Persistent toxicities caused by previous anticancer therapy, excluding alopecia, notyet improved to Grade ≤ 1 or baseline
- Spinal cord compression or brain metastases unless treated
- Leptomeningeal carcinomatosis
- Clinically significant corneal disease
- Active hepatitis or uncontrolled hepatitis B or C virus infection
- Uncontrolled infection requiring IV antibiotics, antivirals or antifungals eg,dromal symptoms
- Significant cardiac diseases
- History of non-infectious Interstitial lung disease (ILD)/pneumonitis that requiredds
- Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washoutd
- Prior exposure to anticancer therapies without an adequate treatment washout period
- Prior treatment with TROP2-directed Anti-drug antibody ADC Antibody-drug conjugate(ADCs), other ADCs with deruxtecan payload
- Severe hypersensitivity to Dato-DXd monoclonal antibodies polysorbate 80 or otherbodies.
- Pregnant, breastfeeding, planning to become pregnant.
Updated on
01 Aug 2024.
Study ID: D926UC00001, BALL-AZ-TROPION-PAN-03, 1996861
